The FDA and Drug Safety

Your Feb. 19 editorial, “In the Dark About Drugs,” was too tepid. As an internist with many senior patients, I find it troubling that the Food and Drug Administration has agreed to allow the sale of certain Cox-2 inhibitors that have been shown to almost double the likelihood of a heart attack or a stroke in high-risk individuals. Placebo effects are very powerful. I realize that it is part of our retail culture to believe that, if a pill costs $3, it must relieve pain better than an over-the-counter pill that costs 30 cents. It follows that some patients may honestly feel that only the more expensive pill helps them. Nevertheless, it should be pointed out that there are no credible double-blind studies showing that the $3 pills are any stronger or really “safer on the stomach” over the long term than the far less expensive pills that apparently do not carry the risk of a cardiovascular disaster.

In the older arthritic population, whose members are the most likely long-term consumers, it is difficult to define those patients who are at increased risk because many heart attacks and strokes occur in patients with no recognizable risk factors or, because in an era of mandated 10-minute office visits, risk factors will never be evaluated.

Arthur D. Silk MD

Garden Grove

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The FDA allowing pharmaceutical companies to spend billions of their customers’ dollars stoking inappropriate demand for their products by direct-to-consumer advertising and trying to counteract this with the posting of difficult-to-interpret information on obscure websites is like hosing gasoline onto a fire with one hand and squirting it with a water gun with the other.

Hyman J. Milstein MD

Studio City

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Re “FDA Advisors OK Disputed Pain Relievers,” Feb. 19: In theory, I believe that informed adults should have the right to make their own healthcare decisions in cases such as the Cox-2 painkillers, weighing the risk of stroke or heart attack against the upside of pain relief. However, with the recent willingness of the FDA to consider the reintroduction of Vioxx to the market, it sounds as if, once again, it is responding more to pressure from the pharmaceutical industry and its multibillion-dollar loss of income than to the responsibility to protect the health and safety of the public.

If public safety were indeed the primary concern of the FDA, we would no longer see tobacco products on the market, with their irrefutable long-term side effects, with no upside other than the obscene revenue they produce for the industry and, as in the case of my own 92-year-old mother who has suffered from emphysema for 20 years, cost the government astronomical amounts in healthcare costs for the victims.

Jill Rubenstein

Bell Canyon

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In addition to questions of FDA oversight, shouldn’t we revisit the issue of direct pharmaceutical advertising to the consumer? That is propaganda, not information. Clear, correct, balanced drug information should be freely available to anyone who wants it. However, helping consumers make informed drug choices also requires the input of the individual’s physician.

You refer to the difficulty that panels of medical experts have in weighing the risks and benefits of drugs. Yet that is exactly what physicians must do every time we see a patient. The locus of informed decision-making ought to be in the doctor-patient encounter, where the doctor’s expertise and an understanding of the individual’s specific health needs are as much a part of the discussion as the patient’s knowledge, opinion and desires.

Granted, physicians are the prime target of drug advertising. Shame on us if we rely on that rather than weighing the evidence for ourselves. Perhaps if less money were spent on advertising to both consumers and physicians, the price of drugs could be reduced.

Mary Jeanne Buttrey MD

Torrance

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In your Feb. 19 editorial, you refer to the new Drug Safety Board that the FDA has requested. Evidently the FDA, whatever it is doing with a billion-dollar budget and 10,000 employees, is not getting around to making sure that drugs are safe. It wants a new board to do that. You called for more vigorous FDA regulation to give consumers more information on drugs. Anyone who gets a prescription today knows that more information is already provided than a layman can assimilate. The experts at the FDA cannot seem to make safety decisions with this information. Is the solution really more boards and more power for the FDA?

Richard E. Ralston

Exec. Dir., Americans for

Free Choice in Medicine

Newport Beach